Two groups of patients with advanced cancer of the prostate received adjuvant immunotherapy by direct intratumor injection of BCG. The first group had advanced metastatic disease that was failing to respond to conventional hormone therapy. The second group were new cases of stages III and IV tumor who were previously untreated and who had had a transurethral resection of the prostate and orchiectomy followed by BCG immunotherapy. The clinical and pathologic findings for both groups of patients are described.—Natl Cancer Inst Monogr 49: 351-353, 1978.

For effective immunotherapy with BCG, direct tumor contact may be essential (1). The prostate is a suitable organ for direct intratumor injection. This paper gives the results of preliminary clinical studies designed to answer three fundamental questions. 1) Can an immune response be induced in the prostate? 2) Is the response harmful to the normal tissues of the genitourinary tract? 3) Does this response cause tumor destruction in prostate carcinoma? Two groups of patients have been studied (2, 3). The first had advanced disease that no longer responded to therapy, and the second had advanced disease previously untreated. The first group of 6 patients continued to receive 1 mg